NCT05950087Recruiting
Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
Source: ClinicalTrials.gov · Last updated 18 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Cervical cancer CC is the most common malignant tumor in the female reproductive system, seriously endangering women's health and life, and is one of the leading causes of death for women worldwide.Globally, HPV causes about 85% of cervical cancers and about 60% of oropharyngeal cancers, causing more than 500,000 cancers each year.ctDNA is a potential biomarker because it contains tumor-specific genetic and epigenetic abnormalities that can be used in cancer diagnosis and prognosis prediction.MRD is considered a promising prognostic marker that can be used to identify individuals at increased risk of recurrence and individuals who may benefit from treatment.The expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer was analyzed by liquid biopsy ctDNA detection technology, which predicted the efficacy of cervical cancer radiotherapy and chemotherapy, which was helpful for monitoring and estimating the risk of disease recurrence after cervical cancer radiotherapy and chemotherapy, and verified the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after cervical cancer radiotherapy and the basis for optimal chemotherapy time node selection.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jun 2023
- Start date
- 1 Nov 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Guizhou Provincial People's Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05950087
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Nov 2022 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Those who are allergic to rubber products.
- Those with severe acute infection and uncontrolled or purulent and chronic infection wounds that do not heal, chronic hepatitis B active stage, active tuberculosis, syphilis outbreak and AIDS.
- Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and intractable hypertension.
- Those with neurological or psychiatric diseases or mental disorders that are not easy to control, poor compliance, unable to cooperate with and describe treatment responses, uncontrolled primary brain tumors or central nervous system metastases, and those with obvious cranial hypertension signs or neuropsychiatric symptoms.
- with malignant serous effusion.
- History of severe enteritis and cystitis, bleeding, intestinal perforation, rectovaginal fistula, rectoval bladder fistula, etc.
Other
- Those who have participated in other clinical trials.
- Other situations in which the investigator believes that the subject is not suitable to participate in this experiment
Who the study is looking for
- Age: ≥ 18 years old, ≤ 75 years old.
- Pathological histologic confirmation of cervical cancer.
- Imaging or PET/CT examination can be performed to understand the tumor and complete all follow-up.
- Measurable lesions before treatment.
- Good physical condition: ECOG score 0-1 (or KPS score 70-100).
- Estimated survival≥ 6 months.
- The baseline blood routine and biochemical indexes before radiotherapy and chemotherapy met the following standards: hemoglobin ≥ 80g/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT, AST ≤ 2.5 times the normal upper limit; Serum albumin ≥ 30 g/L.
- There are three preoperative items: if the patient has syphilis, plum repellent therapy is required before treatment.
- The patient has no history of allergy to rubber products.
- Cardiopulmonary function is basically normal
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yong Li Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.